FDA Shelves Fast-Track Drug Voucher Program Launched by Ex-Chief Makary

The U.S. Food and Drug Administration has quietly shelved the Commissioner's National Priority Voucher program, the fast-track drug review scheme launched in June 2025 by former Commissioner Marty Makary, Reuters reported on Thursday, citing six sources familiar with the matter and internal documents.

The decision effectively ends one of the most controversial experiments in recent FDA history. It promised to cut drug review times to one or two months for urgent national priorities, but critics warned it risked favouring companies willing to meet President Donald Trump's demands.

Key Points

• Reuters reported on Thursday, November 12, 2026, that the FDA has shelved the Commissioner's National Priority Voucher program, citing six sources and internal documents.
• Launched in June 2025 by former Commissioner Marty Makary, it aimed to cut drug review times to one or two months for therapies addressing urgent unmet health needs.
• Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left the FDA in May 2026; several were approved eight months or more early.
• No new drug has received a voucher since Makary's departure, and the executive council of political appointees that oversaw the reviews has gone dormant.
• The nine drugs still in the program are now overseen by FDA career scientists, and companies have been told the agency is keeping applications open.

What Happened

According to Reuters, companies were told by FDA leadership that the agency is not moving forward with the program, although submitted applications remain open and do not advance. The FDA has been without a commissioner since May, when Makary left.

The executive council of political appointees that oversaw reviews has gone dormant. Its members included former acting drug center director Tracy Beth Hoeg and former biologics chief Vinay Prasad, both of whom left the FDA earlier this year. HHS spokesperson Emily Hilliard said the pilot is ongoing and the FDA is reviewing feedback from a June public hearing, a claim at odds with the sources' account of a program stopped in all but name.

Background and Context

Makary launched the program in June 2025 as one of his signature initiatives. For drugs addressing national priorities such as urgent unmet health needs, the FDA would compress a review that normally takes around ten months, or about six for priority reviews, into just one or two months.

The scheme was designed to be selective. Only a small number of drugs would receive a voucher, and a council of senior political appointees would oversee the reviews, cutting through the process drugmakers have long blamed for delays. Supporters said it would get important new treatments to patients faster.

But the design drew sharp criticism. Because the council was made up of political appointees, critics warned it risked preferential treatment for companies that met President Donald Trump's demands, such as offering drugs at lower prices.

The FDA Voucher Program in Numbers

The figures reported by Reuters show a program that delivered real speed. Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary left in May 2026. For several drugs, approval came eight months or more early, a substantial saving where every month matters to patients waiting for treatment.

Yet the numbers also show how quickly the scheme faded once its champion left. No new voucher has been issued since May, and the nine drugs still in the program are now overseen by FDA career scientists. The council that once fast-tracked reviews no longer meets.

Reactions and Quotes

The Department of Health and Human Services stopped short of confirming the program's end. "The pilot is ongoing and the FDA is reviewing feedback from a June public hearing to refine the framework," HHS spokesperson Emily Hilliard said, in the only on-the-record statement reported by Reuters.

Critics had warned from the launch that the scheme risked preferential treatment for companies meeting President Donald Trump's demands, such as offering drugs at lower prices. Their central concern was whether a fast lane run by political appointees could stay free of political favour.

Supporters pointed to the results: a dozen approvals from 22 vouchers, with several drugs reaching patients eight months or more ahead of schedule. The question now is whether any of that speed survives under the career scientists who inherited the nine remaining drugs.

Why It Matters

First, it closes a fast lane drugmakers had begun to count on. Companies that received vouchers saw their drugs approved months earlier, and other firms were watching the pilot as a possible route to market.

Second, it signals how the Trump administration's early health agenda is faring without its original leaders. Makary left in May, and the two senior officials who ran the voucher council, Hoeg and Prasad, have also gone. Programs built around political appointees can unravel quickly when those appointees leave.

Third, it leaves a question mark over drug review times. The standard FDA review takes around ten months, and even priority reviews take about six. The voucher program showed one to two months was possible for selected drugs. With the scheme shelved, patients return to the normal timetable, with no replacement fast lane offered.

What Happens Next

The nine drugs still in the program will continue under FDA career scientists, who will handle their reviews through the agency's normal processes. Companies with applications already submitted have been told they stay open, but they will not advance under the voucher scheme.

The FDA says it is reviewing feedback from the June public hearing to refine the framework, which leaves the door open in theory to a revived program. But with no commissioner since May and the oversight council dormant, any revival would need a new leader to champion it.

Drugmakers, patient groups and lawmakers will now watch for who President Trump names as the next FDA commissioner, and whether that person revives the fast-track idea or lets it fade.

Frequently Asked Questions

What was the FDA voucher program?
The Commissioner's National Priority Voucher program, launched in June 2025 by former FDA Commissioner Marty Makary, aimed to cut drug review times to one or two months for therapies addressing urgent national priorities.

Why has the FDA shelved the program?
Reuters reported, citing six sources and internal documents, that the agency is not moving forward with it. No new vouchers have been issued since Makary left in May 2026.

How many drugs were affected?
Of the 22 drugs given a voucher, a dozen have been approved, including five since Makary's departure. Nine drugs remain in the program under FDA career scientists.

Does shelving the program slow drug approvals?
For drugs that would have received a voucher, yes. Standard FDA reviews take around ten months and priority reviews about six, while the voucher program aimed for one to two months.

What happens to the nine drugs still in the program?
They remain under review by FDA career scientists. Applications stay open, but they will not advance under the voucher scheme, and no new vouchers are being issued.

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